5 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Tibial Component Modular. orthopedic prosthesis. Model Nos: Small, W 16-2817/32 Medium, W 16-2817/35 Large, W 16-2817/37
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·July 20, 2022
DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·April 19, 2023
SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C
FDA Enforcement
Class II
·Ongoing·FUJIFILM Healthcare Americas Corporation·September 21, 2022
REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488; C24317; C28652; C37500; D04164; C44703; C57017; C69412; C69413; C73942; C73941; C88470; C88471 The Normand Info REMISOL Advance Data Manager collects and manages data and workflow for 128 connections (Beckman Coulter Instruments, automations, LIS&). It can also be connected to a host system. It provides data management capabilities such as automatic results validation, delta checking, reflex testing, quality control, results editing, archiving and restoration of patient results.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·July 2, 2025
AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·August 3, 2022